Lasticom

Patient Information Leaflet

LASTICOM 0,5 mg/ml eye drops, solution

Azelastine hydrochloride
Please read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 2 days. Relief from allergic conjunctivitis symptoms typically begins within 15–30 minutes.
• In this patient information leaflet, Lasticom 0,5 mg/ml eye drops, solution is referred to as Lasticom.

Contents of this leaflet:

1. What Lasticom is and what it is used for
2. What you need to know before using Lasticom
3. How to use Lasticom
4. Possible side effects
5. How to store Lasticom
6. Contents of the pack and other information

1. What Lasticom is and what it is used for

Lasticom contains the active substance azelastine hydrochloride, which belongs to a group of medicines called antiallergic agents (antihistamines). Antihistamines work by preventing the effects of substances such as histamine, which the body produces during an allergic reaction. Lasticom has been shown to reduce ocular inflammation.
Lasticom can be used for the treatment and prevention of eye disorders caused by hay fever (seasonal allergic conjunctivitis) in adults and children from 4 years of age onwards.
Lasticom can be used for eye disorders caused by allergies to substances such as house dust mites or animal fur (perennial allergic conjunctivitis) in adults and children from 12 years of age onwards.
Consult your doctor if you do not feel better or if you feel worse after 2 days.
Lasticom is not indicated for the treatment of ocular infections.

2. What you need to know before using Lasticom

Do not use Lasticom:

• if you are allergic to azelastine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Lasticom:

• if you are unsure whether your eye symptoms are caused by an allergy. In particular, if only one eye is affected; if your vision is impaired; or if your eye burns but you have no nasal symptoms, you may have an infection rather than an allergy;
• if your symptoms worsen or last longer than 48 hours without noticeable improvement despite using Lasticom;
• if you wear contact lenses.

Children and adolescents
For the treatment of eye disorders caused by hay fever (seasonal allergic conjunctivitis):
do not administer this medicine to children under 4 years of age, as safety and efficacy have not been demonstrated.
For the treatment of eye disorders caused by an allergy (non-seasonal (perennial) allergic conjunctivitis):
do not administer this medicine to children under 12 years of age, as safety and efficacy have not been demonstrated.

Other medicines and Lasticom
Although no interactions with other medicines are known, inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
When using Lasticom, you may experience transient blurred vision. If this occurs, do not drive or operate machinery until your vision is clear again.

Lasticom contains benzalkonium chloride
This medicine contains 0.00375 mg of benzalkonium chloride per drop, equivalent to 0.00375 mg/0.03 ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may change their colour. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may cause eye irritation, particularly if you have dry eyes or corneal abnormalities (the transparent outer layer of the eye). If you experience unusual eye sensations or sharp pain after using this medicine, speak with your doctor.

3. How to use Lasticom

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Please remember:

• Lasticom must be applied only to the eyes.

Recommended dose:
Ocular disorders caused by hay fever (seasonal allergic conjunctivitis)

• For use in adults and children from 4 years of age
• The usual dose is one drop in each eye in the morning and evening.

If you expect to come into contact with pollen, you may take the usual dose of Lasticom as a preventive measure before going outdoors.
Ocular disorders caused by allergy (non-seasonal (perennial) allergic conjunctivitis)

• For use in adults and children from 12 years of age
• The usual dose is one drop in each eye in the morning and evening.

If your symptoms are severe, your doctor may increase your dose to one drop in each eye up to four times daily. Relief from allergic conjunctivitis symptoms should occur within 15–30 minutes.
Application of Lasticom eye drops
To help you correctly apply the eye drops, it may be helpful to sit in front of a mirror so that you can see what you are doing, especially the first few times.

1. Wash your hands.
2. Gently clean the area around the eyes with a tissue to remove moisture (Figure 1).
3. Unscrew the cap of the bottle and check that the dropper tip is clean.
4. Gently pull down with one finger the lower eyelid of the eye to be treated (Figure 2).
5. Carefully instil one drop into the eye, in the centre of the lower eyelid (Figure 3). Be careful not to touch the eye with the dropper tip.
6. Release the lower eyelid and gently press with your finger on the inner corner of the eye against the side of the nose (Figure 4). While keeping your finger pressed against the nose, blink a few times to help spread the drop over the entire surface of the eye.
7. Wipe away any excess medicine with a tissue.
8. Repeat the same procedure for the other eye.

Figure 1 Figure 2 Figure 3 Figure 4
Duration of treatment
If possible, you should use Lasticom regularly until symptoms disappear.

• Do not use Lasticom for more than 6 weeks.

If you use more Lasticom than you should
It is unlikely that you will experience problems if you have applied too much Lasticom. If you are concerned, contact your doctor. In case of accidental ingestion of Lasticom, contact your doctor or the nearest hospital emergency department immediately.
If you forget to use Lasticom
Use the eye drops as soon as you remember, then take the next dose at your usual time. Do not use a double dose to make up for a forgotten dose.
If you stop using Lasticom
If you stop using Lasticom, your symptoms may return.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
These effects include:

• Common (may affect up to 1 in 10 people): mild eye irritation (burning, itching, tearing) after application of Lasticom. This should not last long;
• Uncommon (may affect up to 1 in 100 people): bitter taste in the mouth. This should disappear quickly, especially if you sip a non-alcoholic drink;
• Very rare (may affect up to 1 in 10,000 people): allergic reaction (such as skin rash and itching).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .

5. How to store Lasticom

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label and on the
packaging. The expiry date refers to the last day of that month.
After opening: do not use this medicine if the bottle has been open for more than 4 weeks.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Package contents and other information

What Lasticom contains
The active substance is azelastine hydrochloride 0.05% (0.5 mg/ml). Each drop contains 0.015 mg of
azelastine hydrochloride.
The other excipients are benzalkonium chloride, disodium edetate, hypromellose, liquid sorbitol
(crystallized (E420i)), sodium hydroxide (E524), and water for injections.
Description of the appearance of Lasticom and contents of the pack
Lasticom is a clear, colourless solution.
Lasticom is supplied in a plastic bottle with a dropper. A bottle contains 6, 8 or 10 ml of eye drops, solution. Not all pack sizes may be marketed.
Marketing Authorization Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60 – 1112 AX Diemen
(The Netherlands)
Manufacturer
Tubilux Pharma S.p.A.
Via Costarica 20/22
00071 Pomezia (Rome)
Italy
This medicinal product is authorized in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Austria: Allergodrop
Germany: Allergodil akut Augentropfen
Irlanda: Azelastine Eye Drops
Italy: Lasticom
The Netherlands: Carelastin azelastine oogdruppels
United Kingdom (Northern Ireland): Azelastine
Spain: Corifina
Sweden: Oculastin